(30 days)
No
The summary describes a mechanical bone plate for fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device provides mechanical fixation for bone segments, which is a supportive rather than a therapeutic function (i.e., it doesn't treat a disease or condition).
No
This device is a bone plate intended for internal fixation, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "bone plate" and mentions physical components like "screw holes" and "screws," indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text clearly describes a bone plate used for internal fixation of bone segments during surgery. It is a physical implant used to stabilize bone, not a device that analyzes biological samples.
- Intended Use: The intended use is for "internal fixation of corrective osteotomies to the symphysis region of the mandible," which is a surgical procedure involving bone manipulation.
Therefore, based on the provided information, the Lee Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures): The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure.
Product codes
JEY
Device Description
This submission describes a bone plate intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). It is designed to provide fixation to an advanced anterior mandibular bone segment. Screw holes allow for attachment to the anterior mandible and the osteotomized segment. 1.7 mm and 2.0 mm diameter screws are used to attach the plate to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
symphysis region of the mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR | | 1997
Ms. Kristyn R. Waski Product Engineer -- Special Projects Howmedica Leibinger; Incorporated ---------14540 Beltwood Parkway East Dallas, Texas 75244
K970911 Re : Trade Name: Lee Plate Requlatory Class: II JEY Product Code: March 10, 1997 Dated: March 12, 1997 Received:
Dear Ms. Waski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Fart 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
J
1
Page 2 - Ms. Waski
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
thy A. Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Lee Plate
Indications for Use:
The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures): The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Sumer Kiwilili |
|---|---|
| Division of Dental, Infection Control, and General Hospital Reviews | |
| 510(k) Number | K970911 |
Prescription Use or Over-The-Countere-Counter Use
ろ
(Optional Format 1-2-96)
3
KA70911
510(k) Summary
Small Bone Plate
Howmedica Leibinger Inc.
APR | | 10
Device Proprietary Name:
Lee Plate
Device Common Name:
Bone Plate 872.4760
Name of Submitter:
Classification Name:
Contact Person:
Kristyn Waski Quality Assurance/Regulatory Affairs Engineer Howmedica Leibinger Inc. 14540 Beltwood Pkwy., East Dallas, TX 75244 Telephone: (972) 392-3636 Fax: (972) 392-7258
Date Prepared:
March 10, 1997
Summary:
This submission describes a bone plate intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). It is designed to provide fixation to an advanced anterior mandibular bone segment. Screw holes allow for attachment to the anterior mandible and the osteotomized segment. 1.7 mm and 2.0 mm diameter screws are used to attach the plate to bone.
Equivalance for this device is based on similarities in intended use. material. design and operational principle to the Profil-O-Plastic Chinplate [K862534 Paulus Titanium Mini Bone Plates and Screws). Both plates are intended for use in the fixation of corrective mandibular osteotomies. Both plates are manufactured from commercially pure titanium. Both the Lee Plate and the Profil-O-Plastic Plates are contoured plates with screw holes to allow for attachment to mandibular bone. The operational principle and indications and contraindications are equivalent for both of these devices.